Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K033497 |
Device Name |
BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM |
Applicant |
C.R. BARD, INC. |
PO BOX 1740 |
1625 WEST 3RD STREET |
TEMPE,
AZ
85281 -1740
|
|
Applicant Contact |
AYMEE R BERRY |
Correspondent |
C.R. BARD, INC. |
PO BOX 1740 |
1625 WEST 3RD STREET |
TEMPE,
AZ
85281 -1740
|
|
Correspondent Contact |
AYMEE R BERRY |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/05/2003 |
Decision Date | 02/04/2004 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|